2023年全球获批上市的原创新药:回顾与展望  

Global approved new drugs in 2023:retrospect and prospect

作　　者：杨臻峥[1] 苏晓语 孙友松 陈倩 王昀[5] YANG Zhen-zheng;SU Xiao-yu;SUN You-song;CHEN Qian;WANG Yun(Editorial Office of Progress in Pharmaceutical Sciences,China Pharmaceutical University,Nanjing 210009,China;State Key Laboratory of Natural Medicines,China Pharmaceutical University,Nanjing 210009,China;Shanghai Pharma Digger Technology Co.,Ltd.,Shanghai 201210,China;The University of Auckland,Auckland 1023,New Zealand;Women's Hospital of Nanjing Medical University/Nanjing Women and Children's Healthcare Hospital,Nanjing 210004,China)

机构地区：[1]中国药科大学《药学进展》编辑部,南京210009 [2]中国药科大学多靶标天然药物全国重点实验室,南京210009 [3]上海递鸽医药科技有限公司,上海201210 [4]奥克兰大学,奥克兰1023 [5]南京医科大学附属妇产医院/南京市妇幼保健院,南京210004

出　　处：《中国新药杂志》2024年第16期1633-1640,共8页Chinese Journal of New Drugs

摘　　要：2023年对于生物医药行业而言是具有里程碑意义的一年,在这一年中美国、欧洲、日本与中国均积极推动新药创制和新兴技术发展,在针对新型疾病的治疗方案、基因编辑技术等领域获得重大突破,利用人工智能/大数据等先进技术提升了研发效率和质量,全球生物医药行业在创新、市场需求、产业链整合和国际化等方面呈现出积极的发展趋势。本文梳理与总结2023年美国、欧洲、日本和中国获批上市的新药,并对2024年新药研发和生物医药发展态势进行展望,以期为新药研发相关研究提供参考。2023 marks a milestone year for the biopharmaceutical industry.In this year,the United States,Europe,Japan,and China have actively promoted the creation of new drugs and emerging technologies,achieved breakthroughs in areas such as treatment options for new diseases and gene editing technology,and improved research and development efficiency and quality by leveraging advanced technologies like artificial intelligence and big data.The global biopharmaceutical industry has demonstrated positive trends in innovation,market demand growth,industry chain integration,and internationalization.This article summarized and sorted out the approved drugs in the United States,Europe,Japan,and China in 2023,and provided an outlook for new drug research and development and the development trend of the biopharmaceutical industry in 2024,aiming to provide a reference for researchers in new drug development.

关 键 词：创新药 首创类药物 细胞与基因治疗 孤儿药 基因编辑 

分 类 号：R95[医药卫生—药学]